德克希艾斯 2-50 GBq放射核素孳生器

国家: 台湾

语言: 中文

来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

可用日期:

昶洋貿易股份有限公司 台北市大安區光復南路568號11樓 (86713490)

ATC代码:

V09FX

药物剂型:

注射劑

每包单位数:

99mTc放射活度達25GBq的孳生器以鋁製屏蔽防護，達50GBq則以鎢製屏蔽防護

类:

製　劑

处方类型:

限由醫師使用

厂商:

INSTITUT NATIONAL DES RADIOELEMENTS "IRE" B-6220 FLEURUS/BELGIUM BE

治疗领域:

Various thyroid diagnostic radiopharmaceuticals

疗效迹象:

用於甲狀腺、唾液腺、胃黏膜異位(Meckel's diverticulum)、淚管之造影

產品總結:

有效日期: 2025/04/30; 英文品名: Tekcis 2-50 GBq radionuclide generator

授权日期:

2015-04-30

资料单张

_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Tekcis 2-50 GBq radionuclide generator
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium pertechnetate (99mTc) injection is produced by means of a
(99Mo/99mTc) radionuclide generator.
Technetium (99mTc) decays with the emission of gamma radiation with a
mean energy of 140 keV and a
half-life of 6.02 hours to technetium (99Tc) which, in view of its
long half-life of 2.13 x 105 years, can be
regarded as quasi stable.
The radionuclide generator containing the parent isotope 99Mo,
adsorbed to a chromatographic column,
delivers sodium pertechnetate (99mTc) injection in sterile solution.
The 99Mo on the column is in equilibrium with the formed daughter
isotope 99mTc. The
generators are supplied with the following 99Mo activity amounts at
activity reference time
which delivers in equilibrium the following technetium (99mTc) amounts
:
99mTc activity
(Maximal eluable activity at
calibration date, 12h CET)
2
4
6
8
10
12
16
20
25
50
GBq
99Mo activity
(at calibration date, 12h CET)
2.5
5
7
9.5
12
14.5
19
24
30
60
GBq
Each mL of sodium pertechnetate(99mTc) solution contains 3.6 mg of
sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Radionuclide generator
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
1.
Use on Thyroid scintigraphy, Salivary gland scintigraphy, Location of
ectopic gastric mucosa (Meckel's
diverticulum), Lacrimal duct scintigraphy.
2. Labelling of various kits for radiopharmaceutical preparation
developed and approved
for radiolabelling with such solution.
This medicinal product is for diagnostic use only.
4.2. Posology and method of administration
This medicinal product is for use in designated nuclear medicine
facilities only, and should
only be handled by authorized personnel.
Posology
Sodium pertechnetate (99mTc) is normally administered intravenously at
activities which vary widely
according to the clinical information required and the equipment
employed. Other activities may be
justifiable. The i